M-ARS ACL: Anatomic Ribbon Surgery System

GUDID 07630040715751

Femoral Button

Medacta International SA

Ligament bone anchor
Primary Device ID07630040715751
NIH Device Record Key1778654a-792b-48cd-b6f0-9a2da0e091a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameM-ARS ACL: Anatomic Ribbon Surgery System
Version Model Number05.05.0002
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630040715751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-08
Device Publish Date2017-10-28

On-Brand Devices [M-ARS ACL: Anatomic Ribbon Surgery System]

07630040715751Femoral Button
07630040715744Tibial Pull Suture Plate (PSP)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.